Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Temozolomide in Treating Patients With Low-Grade Glioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00313729
Recruitment Status : Completed
First Posted : April 12, 2006
Results First Posted : January 23, 2019
Last Update Posted : February 7, 2019
Sponsor:
Information provided by (Responsible Party):
Susan Chang, University of California, San Francisco

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with supratentorial low-grade glioma.


Condition or disease Intervention/treatment Phase
CNS Tumor, Adult Drug: temozolomide Phase 2

Detailed Description:

OBJECTIVES:

Primary

  • Determine the efficacy of temozolomide, defined as response rate (complete and partial response), in patients with supratentorial mixed low-grade glioma.

Secondary

  • Assess the safety profile of temozolomide in patients with supratentorial low-grade glioma.
  • Assess the time to tumor progression in patients treated with temozolomide.

OUTLINE: Patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Temozolomide (TEMODAR) in the Treatment of Adult Patients With Supratentorial Low Grade Glioma
Study Start Date : May 1999
Actual Primary Completion Date : September 25, 2014
Actual Study Completion Date : June 12, 2017


Arm Intervention/treatment
Experimental: Temozolomide
Temozolomide
Drug: temozolomide
Chemotherapy
Other Name: Temodar




Primary Outcome Measures :
  1. Response Rate (Complete and Partial Response) [ Time Frame: 12 months ]
    Assessment of treatment response was determined by MRI in conjunction with neurological examination and steroid requirement assessment derived from Macdonald's criteria. Complete response was defined as complete disappearance of lesion on consecutive MRI scans with stable or improved neuro exam and steroids. Partial response was defined as a 50% reduction in lesion size or that tumor burden was "definitely better" than prior scan with stable or improved neuro exam and steroids.


Secondary Outcome Measures :
  1. Time to Tumor Progression [ Time Frame: time from registration until date of the first documented progression, an average of 1 year ]
    Progressive disease was defined as definite enlargement of any existing lesion or any new lesion based on modified Macdonald's criteria.

  2. Safety Profile [ Time Frame: Time from registration up to 13 months ]
    Number of participants with treatment related grade 2-4 adverse events as defined by CTCAE 3.0



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically proven supratentorial low-grade (grade II) glioma of any of the following histologic subtypes:

    • Oligodendroglioma
    • Astrocytoma
    • Oligoastrocytoma
  • Has undergone surgical resection or biopsy within 35 days after diagnosis of low-grade glioma

    • Study treatment must begin between 14 days and 4 months after surgical resection or biopsy
  • Evaluable disease by gadolinium-MRI

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 60-100%
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 10 g/dL
  • Creatinine < 1.5 times upper limit of normal (ULN)
  • BUN < 1.5 times ULN
  • Bilirubin < 1.5 times ULN
  • SGOT < 2.5 times ULN
  • Alkaline phosphatase < 2 times ULN
  • Life expectancy > 12 weeks
  • No nonmalignant systemic disease resulting in the patient being a poor medical risk
  • No acute infection requiring intravenous antibiotics
  • No frequent vomiting or medical condition that would interfere with oral medication intake (e.g., partial bowel obstruction)
  • No other concurrent malignancies except surgically cured carcinoma in situ of the cervix or basal cell or squamous cell carcinoma of the skin

    • Prior malignancies must be in remission for ≥ 5 years
  • No known HIV positivity
  • No AIDS-related illness
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior radiotherapy, interstitial brachytherapy, or radiosurgery for low-grade glioma
  • No prior biological therapy or chemotherapy for low-grade glioma
  • No other concurrent chemotherapy
  • No concurrent radiotherapy or biological therapy
  • No concurrent prophylactic growth factors
  • No concurrent epoetin alfa
  • No other concurrent investigational drugs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00313729


Locations
Layout table for location information
United States, California
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
Investigators
Layout table for investigator information
Study Chair: Susan M. Chang, MD University of California, San Francisco

Layout table for additonal information
Responsible Party: Susan Chang, MD, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00313729     History of Changes
Obsolete Identifiers: NCT00187642
Other Study ID Numbers: CDR0000448883
99102 ( Other Identifier: UCSF Cancer Center Protocol Number )
BTRC-9902
H7858-16278-07 ( Other Identifier: UCSF IRB )
First Posted: April 12, 2006    Key Record Dates
Results First Posted: January 23, 2019
Last Update Posted: February 7, 2019
Last Verified: January 2019

Keywords provided by Susan Chang, University of California, San Francisco:
adult oligodendroglioma
adult mixed glioma
adult diffuse astrocytoma
adult pilocytic astrocytoma
adult pineal gland astrocytoma

Additional relevant MeSH terms:
Layout table for MeSH terms
Glioma
Central Nervous System Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases
Temozolomide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents